Influence of Stress on Non Surgical Periodontal Treatment
Primary Purpose
Chronic Periodontitis
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Non surgical periodontal treatment
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Periodontitis
Eligibility Criteria
Inclusion Criteria:
- Severe generalized chronic periodontitis
- Minimum 15 teeth
- Attachment loss > 5mm
- 30% of sites affected- 5% of pockets>5mm
- Bone loss- Bleeding on probing
Exclusion Criteria:
- Patient at risk of endocarditis
- Pregnant women
- Patient under therapy for depression
- Patient treated for periodontal diseases previously
Sites / Locations
- Service de parodontologie
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
questionary
Arm Description
Outcomes
Primary Outcome Measures
Changing depths of periodontal pockets
Secondary Outcome Measures
Full Information
NCT ID
NCT02568163
First Posted
June 25, 2013
Last Updated
August 19, 2019
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT02568163
Brief Title
Influence of Stress on Non Surgical Periodontal Treatment
Official Title
Influence of Stress on Non Surgical Periodontal Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
The number of subjects were underestimated, which implies a reduction in the number of subjects required.
Study Start Date
September 2013 (Actual)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Treatment of periodontal diseases is influenced by several risk factors. Psychological stress is considered as one of them. Aim of this study is to assess if stress influences results of non surgical periodontal treatment in severe chronic forms of periodontitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
questionary
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Non surgical periodontal treatment
Primary Outcome Measure Information:
Title
Changing depths of periodontal pockets
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Severe generalized chronic periodontitis
Minimum 15 teeth
Attachment loss > 5mm
30% of sites affected- 5% of pockets>5mm
Bone loss- Bleeding on probing
Exclusion Criteria:
Patient at risk of endocarditis
Pregnant women
Patient under therapy for depression
Patient treated for periodontal diseases previously
Facility Information:
Facility Name
Service de parodontologie
City
Strasbourg
State/Province
Bas Rhin
ZIP/Postal Code
67000
Country
France
12. IPD Sharing Statement
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Influence of Stress on Non Surgical Periodontal Treatment
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